Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
31753–31776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 2016
OPTIS Metallic Stent Optimization E.4 SW
K160878 · NQQ
Lightlab Imaging, Inc.
General & Plastic Surgery · 91d
Cleared Jun 29, 2016
Xpert Carba-R
K160901 · POC
Cepheid
Microbiology · 89d
Cleared Jun 29, 2016
Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter...
K161186 · KGE
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 63d
Cleared Jun 29, 2016
Ablation Confirmation
K161285 · JAK
Neuwave Medical, Inc.
Radiology · 51d
Cleared Jun 28, 2016
Regular and Special Umbilical Cord Clamp and Cutter
K152350 · NBZ
Ningbo Feite Medical Device Co., Ltd.
Obstetrics & Gynecology · 313d
Cleared Jun 28, 2016
Jeesung Safety Syringe and Single Use Needles
K152606 · MEG
Jeesung Medical Co., Ltd.
General Hospital · 291d
Cleared Jun 28, 2016
LED Curing Light GT-2000
K153078 · EBZ
Monitex Industrial Co., Ltd.
Dental · 249d
Cleared Jun 28, 2016
SCATTER CORRECTION FOR CXDI SERIES
K153312 · MQB
Canon, Inc.
Radiology · 224d
Cleared Jun 28, 2016
PowerMidline Catheter
K153393 · PND
C.R. Bard, Inc.
General Hospital · 217d
Cleared Jun 28, 2016
MRI Patient Monitor TeslaDUO
K153739 · MWI
Mipm Mammendorfer Institut Fur Physik...
Cardiovascular · 183d
Cleared Jun 28, 2016
Surgical Navigation Advanced Platform (SNAP)
K160584 · LLZ
Surgical Theater, LLC
Radiology · 119d
Cleared Jun 28, 2016
Gibralt® Spine System and Gibralt® Occipital Spine System
K160697 · NKG
Exactech, Inc.
Orthopedic · 106d
Cleared Jun 28, 2016
PressON Pro Spinal Fixation System
K160820 · NKB
Nexus Spine, LLC
Orthopedic · 96d
Cleared Jun 28, 2016
Nanovis Intervertebral Body Fusion System and FortiCore®
K160874 · MAX
Nanovis, LLC
Orthopedic · 90d
Cleared Jun 28, 2016
VIDAS B.R.A.H.M.S. PCT (PCT)
K160911 · PMT
bioMerieux, Inc.
Microbiology · 88d
Cleared Jun 28, 2016
CoRoent® Ti-C System
K160916 · MAX
Nu Vasive, Incorporated
Orthopedic · 88d
Cleared Jun 28, 2016
F1 MPS Modular Pedicle Screw System
K160926 · NKB
Degen Medical
Orthopedic · 85d
Cleared Jun 28, 2016
Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape
K161024 · JOJ
Canadian Technical Tape, Ltd.
General Hospital · 77d
Cleared Jun 28, 2016
hipEOS
K161479 · LLZ
Onefit Medical
Radiology · 28d
Cleared Jun 27, 2016
Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode
K151976 · FAS
Omnitech Systems, Inc.
Gastroenterology & Urology · 347d
Cleared Jun 27, 2016
Apogee 5500/Apogee 5300/ Apogee 5800 Digital Color Doppler Ultrasound Imaging...
K160853 · IYN
Shantou Institute of Ultrasonic...
Radiology · 91d
Cleared Jun 27, 2016
Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine...
K161214 · DIO
Guangzhou Wondfo Biotech Co., Ltd.
Toxicology · 59d
Cleared Jun 27, 2016
EndoChoice Water Bottle Cap Irrigation System
K161482 · FEQ
Endochoice, Inc.
Gastroenterology & Urology · 27d
Cleared Jun 24, 2016
Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug...
K152122 · DKZ
Alfa Scientific Designs, Inc.
Toxicology · 330d